This is the year that drug- and devicemakers will need to begin reporting – for the whole world to see — the types of financial arrangements they have with physicians and teaching hospitals.

Planning for disclosure is one thing. Actually carrying it out will be another altogether. Are you ready for the host of challenges, headaches and questions that are about to land on your desk? If not, read on …

By Sept. 30, 2014, your every payment to physicians and teaching hospitals will be public. The fallout from such publicity may create a host of problems for drug and device makers like yourself — not least, those $1 million potential fines.

Furthermore, you can expect physicians to carefully scrutinize the data and demand corrections when warranted. Some may dispute what exactly must be reported — even whether you need to report at all.

But here’s help setting up a compliant reporting program to withstand such challenges. Managing Physician Payment Disclosures gets you off to a running start, with:

Key definitions on what information must be reported

Who qualifies under the law and must report, and who is exempt

How to build the "assumptions document" that will form the basis for your reporting strategy

Special considerations for educating physicians and hospitals on implications of the rule

How to avoid simple mistakes that can result in failure to report

How to anticipate potential PR and legal problems disclosure may create

Must companies report payments occurring before a product is approved?

Are consulting fees treated differently than gifts?

Are drug samples considered items of value that must be reported?

Are product discounts reportable?

Are payments for treatment of adverse events reportable?

Does the Sunshine Act preempt all state reporting requirements?

And many others!

Do you relish facing hordes of angry physicians demanding corrections to their data? How about the prospect of $1 million fines? The answer ought to be clear — especially when this easy-to-read Special Management Report can set you on the right path in an hour or two of reading, max.

Managing Physician Payment Disclosures is based in part on a presentation to FDAnews by the following industry experts:

Tim Robinson, executive VP and general counsel, MMIS. Mr. Robinson has worked with numerous Fortune 500 companies to develop innovative products and services in the highly regulated healthcare and pharmaceutical industries.

Mark Linver, managing director of Huron Consulting Group’s Life Sciences practice. Mr. Linver has more than 23 years of experience in implementing solutions that meet the business needs of FDA-regulated pharmaceutical, medical device and biotechnology companies.

Seth Lundy Esq., partner, King & Spalding, and deputy chair of K&S’s FDA and Life Sciences Practice Group. Mr. Lundy is an expert in federal and state regulation of medical device and pharmaceutical manufacturers, healthcare providers and suppliers, as well as corporate compliance, the Anti-Kickback Statute, the Stark law, the False Claims Act, state law compliance and reporting regulations, and Medicare and Medicaid reimbursement.

Here's a suggested list of potential readers:

Drug company officials

Device company officials

Physicians

Hospital officials

Compliance officials

Regulatory Affairs officers

In-house counsel

Sales directors

Finance managers

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